AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

Launched by CONVATEC INC. · Mar 9, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects over 18 years, willing and able to provide written informed consent.
• • Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater.
• • Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 .
• • Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation.
• • Subjects agree to wear compression therapy daily in combination with the trial dressing.
• Exclusion Criteria:
• • Subjects with a history of skin sensitivity to any of the components of the study product.
• • Subjects who have had current local or systemic antibiotics in the week prior to inclusion.
• • Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
• • Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids.
• • Subjects who have participated in a clinical study within the past 3 months.
• • Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).